Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489450
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2007-06-20
Brief Title:
Phase I Study to Investigate the Alcohol Interaction of SK3530
Sponsor:
SK Chemicals Co Ltd
Organization:
SK Chemicals Co Ltd
Study Overview
Official Title:
Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics PKs and safety
Detailed Description:
This study was a randomized open single-dose three-treatment three-period three-sequence crossover study in which subjects were received in random order SK3530 100mg alone 05gKg of alcohol alone and SK3530 plus alcohol together There was a minimum of a 7 day washout period between treatments The alcohol was diluted to 240 mL with water The contents were drunk in 1 minutes or less For SK3530 and metabolite measurement plasma samples were collected at pre-scheduled time and the safety was monitored all through the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None